RedCord in Neurogenic Bowel Dysfunction in Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorUniversity of Castilla-La Mancha
About this trial
The study aims to evaluate the effectiveness of Redcord treatment for neurogenic bowel dysfunction in patients with multiple sclerosis. The main objectives are:
* Assess the impact of Redcord on bowel function and quality of life in multiple sclerosis patients. * Compare the outcomes of Redcord treatment with standard care practices.
Participants will undergo Redcord therapy sessions and their bowel function will be monitored and compared to a control group receiving standard care. The study will measure improvements in bowel control, frequency, and overall patient satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People diagnosed with Multiple Sclerosis according to McDonald's criteria.
EDSS less than 6 points.
Willingness to participate.
Disqualifiers
People with cognitive impairment, which makes it difficult to understand the questionnaires properly.
Pregnant women.
Severe psychological or psychiatric pathology diagnosed.
Trial design
Design model
Parallel
Treatments tested in this trial
Redcord
DevicePerticipants will perform exercises in different plank positions using RedCord® while applying local vibration in: * Supine plank position * Prone plank position * Lateral prone plank position
Control (Standard treatment)
Other interventionParticipants will perform exercises in different plank positions: Supine plank position Prone plank position Lateral prone plank position
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Redcord exercisesExperimental treatment 1 intervention
Group B: Standard exercisesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neurogenic Bowel Dysfunction score (NBDS)
Improvement in bowel control, measured by the Neurogenic Bowel Dysfunction Score (NBD Score) over a period of 24 weeks. Neurogenic Bowel Dysfunction score (NBDS) validated in Spanish is a questionnaire used for the clinical evaluation of colorectal and anal dysfunction. It is used to assess bowel dysfunction in neurological pathologies. It quantifies the severity of bowel dysfunction in 4 categories: very mild (score 0 to 6), mild (score 7 to 9), moderate (score 10 to 13) and severe (score greater than or equal to 14). It consists of 10 items relating to frequency of bowel movements, presence of headache and/or sweating during defecation, use of medication for constipation, time used for each defecation, frequency of bowel movements by digital extraction, frequency of faecal incontinence, medication used for faecal incontinence, presence of anal incontinence, skin problems in the peri-anal area.
Time frame
baseline, 6, 12 and 24 weeksSecondary outcomes
1
Electromyography: Root mean square
A Noraxon Telemyo 12-channel electromyography equipment (Noraxon USA Inc). Electromyography data will be recorded from the rectus abdominis, external oblique, internal oblique, erector spinae and pelvic floor musculature. Rectangular, disposable, 21x41 millimetre, wireless, rectangular electrodes with gel will be used to aid electromyography. A rectal electromyographic probe will also be used to include the pelvic floor musculature. To carry out this assessment, the amplitudes of the electromyographic signals will be recorded using the Root Mean Square (RMS).
Time frame
baseline, 6, 12 and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: